Method and apparatus for diagnostic analyses

Abstract

A method for diagnostic analysis, in particular to identify pathogens, such as viruses, bacteria or other micro-organisms present in a biological sample, comprises a first step of measuring and continuously monitoring the turbidity and / or the concentration of the pathogens, by means of an instrumental reading technique, of a liquid culture medium into which the sample to be analyzed has been inoculated and in which the replication of the pathogens possibly present occurs, said measuring and monitoring being carried out dynamically during the replication of the pathogens growing in the culture medium; and a second step of identifying the pathogens, carried out by taking at least an aliquot of the liquid culture medium containing the biological sample directly obtained from the first step, which has reached a desired value of turbidity according to a standardized value scale, such as the McFarland turbidity scale, and / or of concentration of the pathogens, and using said aliquot directly in mass spectrophotometric identification means (15) in order to identify the pathogens, which means are calibrated in their functioning depending on the measurement results of the first step. The desired values of turbidity and / or of concentration of the pathogens are preliminarily selected, during the first step, on the basis of the specific needs which, on each occasion, are identified in order to carry out the second identification step.

Description

FIELD OF THE INVENTION[0001]The present invention concerns a method and apparatus for diagnostic analyses, in particular to identify pathogens, such as viruses, bacteria or other micro-organisms by means of mass spectrophotometric measurements.BACKGROUND OF THE INVENTION[0002]It is known that an in vitro sensitivity test to antibiotics (antibiogram) provides, on the basis of current international guide lines, to set up a standardized bacterial suspension to test against optimized concentrations (breakpoints) or scale dilutions of antibiotics (M.I.C).[0003]The number of bacteria analyzed must be standardized irrespective of the sensitivity of the method adopted for the test.[0004]The preparation of an inoculum is one of the most critical passages in every sensitivity test or antibiogram. The inoculum can significantly influence the dimensions of the inhibition area.[0005]The choice of the inoculum method is mainly conditioned by practical considerations, but the results are better if...

AI Technical Summary

Benefits of technology

This approach allows for quick, reliable, and cost-effective identification of pathogens, even in the presence of contaminants, by standardizing bacterial load and optimizing sample preparation for mass spectrophotometry, reducing analysis time and improving accuracy.

Problems solved by technology

Values above this range risk blocking the mass spectrophotometer.

It must also be noted that the pellet obtained from the positive sample with the method described in WO'580 does not allow to select the pollutants from the bacteria responsible for the infection in progress.

Consequently, WO'580 has its limitations in discriminating a maximum of two bacteria in the sample to be analyzed, in that the detection algorithm to identify the bacteria using an identification library is not able to discriminate if the number of bacteria present in a sample is more than the two species combined.

Consequently the known technique suffers in particular from the presence of other contaminating bacteria, as well as the bacterium responsible for the infection.

Moreover, this technology can often give mass spectrums which are not very clear with problems of basic interference.

Furthermore, the centrifugation method contributes to lengthening the times and increases the overall costs of analysis.

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